MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN ENDO GIA; STAPLE, IMPLANTABLE

Model Number EGIATRS60AMT

Device Problems Entrapment of Device (1212); Separation Failure (2547)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/28/2017

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter: occurred during a sub total gastrectomy procedure.The reinforced reload was connected to the adapter.The surgeon fully fired the device, however, could not cut the anchoring suture and could not open the jaws.The surgeon opened the jaws by hand with force and cut the excess neoveil sheet.The reload was removed from the tissue without damage.There was no patient harm.The status of the patient is no problem.

Manufacturer Narrative

Evaluation summary: post market vigilance received one device.The visual inspection of the returned product noted that the pushers of were all fired, but the sled was not fully advanced.The jaws were open.The distal suture on the anvil side was still anchored on reinforcement material.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the unreleased sutures may occur if the firing sequence is not completed.In this situation, the internal hinges which release the sutures may not engage fully and reinforcement material may not deploy properly.The information booklet which accompanies each product shipment offers the following as a warning and precaution: when using the device and adapter in challenging applications, the firing sequence may stop prematurely.The propensity to stop prematurely may increase if the reload is in the articulated position.If the firing does stop prematurely, release the blue close/fire button, assess the tissue for obstructions and wait approximately 15-30 seconds to allow tissue to compress.After waiting 15-30 seconds, press the close/fire button to continue the firing stroke.The knife blade will stop automatically at the distal end of the reload when the firing stroke is complete.¿should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO GIA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mc dermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mc dermott rd; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6895029
• MDR Text Key: 87393595
• Report Number: 1219930-2017-07431
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 20884521191010
• UDI-Public: 20884521191010
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K133938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: EGIATRS60AMT
• Device Catalogue Number: EGIATRS60AMT
• Device Lot Number: N7D0322KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2017
• Initial Date FDA Received: 09/26/2017
• Supplement Dates Manufacturer Received: 11/21/2017
• Supplement Dates FDA Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1